510(k) · Cleared
ClearedCobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · NDY Test, Cystatin C
Cleared on Jul 17, 2014 as substantially equivalent to K093680 (Diazyme Laboratories, 2010) and 1 other predicate after a 76-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Jul 17, 2014
- Review
- 76 days
- Class
- Class II
- Product code
- NDY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953239 (1995). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 2 generations backK041627 Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004
- 1 generation backK080811 Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C…Roche Diagnostics Corp. · 2008
- This deviceK141143 Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C…Roche Diagnostics · 2014
- Descendant · cites it directly · 1 of its ownK171072 N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017
- Descendant · cites it directly · 1 of its ownK161817 Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016
- Descendant · 2 generations on · 0 of its ownK242585 Cystatin CSENTINEL CH. SpA · 2025
- Descendant · 2 generations on · 0 of its ownK181082 ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017 · cites it directly1descendant
- K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016 · cites it directly1descendant
- K242585Cystatin CSENTINEL CH. SpA · 2025 · 2 generations on0descendants
- K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −2 | K041627 | Cystatin C Immunoparticles, Control Set, Calibrator | Dako A/S | 2004 | — |
| −1 | K080811 | Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin… | Roche Diagnostics Corp. | 2008 | — |
| 0 (this device) | K141143 | Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator… | Roche Diagnostics | 2014 | — |
| +1 | K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | 2017 | — |
| +1 | K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016 | — |
| +2 | K242585 | Cystatin C | SENTINEL CH. SpA | 2025 | — |
| +2 | K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDY device
- #1 K242585 Cystatin Cscore 10.5 · 5 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093680 | Diazyme Cystatin C AssaySummary page 1…nt. This candidate device is a new reagent that was developed by Roche Diagnostics. The Diazyme Cystatin C Assay was cleared in 510(k) k093680 and serves as the predicate device. The candidate reagent uses the same calibrator that was cle… | 2010 |
| * | K080811 | Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control…Summary page 5…l The following table compares the identical features of the candidate device to equivalence - the predicate device that was cleared in 5 10(k) k093680 and k08081 1. similarities Predicate Device: Candidate Device: Feature… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K171072 (Siemens Healthcare Diagnostics Products GmbH, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093680.
How does its category compare?
All NDY devicesNDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NDY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDY
265in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDY
10in 2025
MAUDE reports naming product code NDY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 95 | 0 | 0 |
| 2008 | 6 | 101 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 265 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Tina-quant Cystatin C Gen.2 is an in vitro test for the quantitative determination of cystatin C in human serum and plasma on Roche/Hitachi cobas c systems. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
The C.fa.s. (Calibrator for automated systems) Cystatin C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The Cystatin C Control Set Gen.2 is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141143: Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141143
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026